Status:
COMPLETED
Prospective SecurAcath Subcutaneous Securement Trial
Lead Sponsor:
Interrad Medical
Conditions:
Central Venous Catheter
Eligibility:
All Genders
18+ years
Brief Summary
To prospectively monitor the safety and performance of the catheter securement device in subjects whose catheter is secured with the Interrad Medical SecureAcath device.
Detailed Description
Peripherally inserted central catheters (PICCs) and Central Venous Catheter (CVC) are widely used to deliver fluids directly to the central venous system and can remain in place for as short as a few ...
Eligibility Criteria
Inclusion
- Age 18 or older
- Requires an intravenous catheter to be placed
Exclusion
- Inability to understand the study or a history of non-compliance with medical advice.
- Unwilling or unable to sign Informed Consent Form (ICF).
- Had a previous catheter placed in the same side within the last 3 months.
- Known central venous thrombosis or occlusion or stenosis on the side of the body to be used for the catheter.
- History of upper extremity venous thrombosis on the side of the body to be used for the catheter.
- Known hypercoagulable disorder.
- Diffuse skin inflammatory condition or rashes on the side to be used for the catheter line.
- Peripheral chemotherapy therapy in the same side as that to be used for the catheter line within 3 months.
- Known hypersensitivity to nickel.
- Any infection associated with positive blood cultures that are still present after 48 hours of antibiotic therapy.
- Previous mastectomy or axillary lymph node dissection on the same side as catheter implant.
- Subjects on chronic or recurrent systemic steroid medications for 6 months or longer.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00903539
Start Date
January 1 2009
End Date
May 1 2011
Last Update
January 31 2012
Active Locations (4)
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1
North Memorial Hospital - Minneapolis Radiology
Robbinsdale, Minnesota, United States, 55422
2
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States, 55102
3
Great Basin Imaging
Carson City, Nevada, United States, 89706
4
Albany Medical Center
Albany, New York, United States, 12208